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FDA’s Accelerated Pathways Are the New Normal
The FDA’s Accelerated Approval, Breakthrough Therapy Designation, Fast Track, Orphan Drug status, and Qualified Infectious Disease Product pathways facilitate faster development and approval of NDAs addressing unmet needs. According to the FDA’s annual report, two-thirds of novel drugs approved in 2015 used at least one accelerated pathway, while a third used two or more. PAREXEL and the nonprofit Network for Excellence in Healthcare Innovation share results of a survey of twenty national, regional, public, and private payers, which explain how they view these pathways and products.
FDA Approves Roche’s Susvimo Refillable Eye Implant for Diabetic Macular Edema
February 4th 2025Roche’s Susvimo, a refillable eye implant for diabetic macular edema, provides continuous delivery of ranibizumab, showing sustained vision improvements with fewer treatments than standard eye injections.
The Future of Fertility: AI, Personalized Medicine, and Ethical Considerations
January 30th 2025Dr. Lawrence B. Werlin, MD, FACOG of HRC Fertility (@md.lawrence.werlin on TikTok), discusses how to combat the spread of misinformation on social media, opportunities that social media presents, advancements in fertility technology, and more.
What Every Pharma CEO Should Know About Unlocking the Potential of Scientific Data
December 11th 2024When integrated into pharmaceutical enterprises, scientific data has the potential to drive organizational growth and innovation. Mikael Hagstroem, CEO at leading laboratory informatics provider LabVantage Solutions, discusses how technology partners add significant value to pharmaceutical R&D, in addition to manufacturing quality.
